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510(k) Data Aggregation
(221 days)
The Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device, Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The colors of the proposed device are Blue, Black, and Indigo.
The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Examination Gloves. This type of medical device is a Class I device and does not fall under the category of AI/ML-powered medical devices that would typically involve the comprehensive testing and data requirements outlined in the prompt's request.
Therefore, the document does not contain the information requested regarding acceptance criteria and study proving device meets acceptance criteria for an AI/ML-powered device. Specifically:
- No AI/ML Component: The device is a physical examination glove, not an AI/ML system.
- No Comparative Effectiveness Study: There is no multi-reader multi-case (MRMC) comparative effectiveness study, as it's not a diagnostic or AI-assisted interpretation device.
- No Standalone Algorithm Performance: The concept of standalone algorithm performance does not apply to a physical glove.
- No Ground Truth Establishment for AI Models: The document describes physical and biological testing for a glove (e.g., tensile strength, pinholes, biocompatibility), not the establishment of ground truth for training or testing an AI model.
- No Training or Test Sets for AI: The terms "training set" and "test set" in the context of AI/ML are not applicable to the non-clinical testing performed for these gloves.
- No Expert Adjudication for AI: The biological and physical tests performed for gloves do not involve expert radiologists or other medical experts establishing ground truth for AI performance.
The document focuses on demonstrating substantial equivalence to a predicate device (K150340) through non-clinical performance testing for physical properties and biocompatibility.
However, to answer the prompt based on the information that is present in the document for this specific device (Powder Free Nitrile Examination Gloves), I will present the acceptance criteria for the physical and biological properties of the gloves and their performance results.
Acceptance Criteria and Device Performance (for Powder Free Nitrile Examination Gloves)
The study proves the device meets the acceptance criteria through non-clinical performance testing, demonstrating substantial equivalence to a legally marketed predicate device (K150340).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ASTM standards (D6319, D6124-06, D5151 06) and ISO 10993 series for biological evaluation. The results consistently "Meet requirement" or show compliance with the specified criteria.
| Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties (from Tables 2/8/14) | |||
| Tensile Strength (Unaged) | To assess the glove's strength before aging. | ≥ 14 MPa | ≥ 14 MPa (Meets requirement of ASTM D6319) |
| Elongation at Break (Unaged) | To assess the glove's elasticity before aging. | ≥ 500% | ≥ 500% (Meets requirement of ASTM D6319) |
| Tensile Strength (Aged) | To assess the glove's strength after accelerated aging. | ≥ 14 MPa | ≥ 14 MPa (Meets requirement of ASTM D6319) |
| Elongation at Break (Aged) | To assess the glove's elasticity after accelerated aging. | ≥ 400% | ≥ 400% (Meets requirement of ASTM D6319) |
| Freedom of Holes (ASTM D5151 06) | To detect holes in medical gloves. | Samples: 500 gloves; AQL: 2.5 (ISO 2859); Criterion: ≤ 21 gloves for water leakage | Requirement met. |
| Residual Powder (ASTM D6124-06) | To determine the amount of residual powder on medical gloves. | Powder residue limit of 2.0 mg/glove | Avg. S: 0.30 mg/glove, M: 0.31 mg/glove, L: 0.45 mg/glove (Requirement met). |
| Biocompatibility (from Tables 6/12/18) | |||
| ISO 10993-10:2010 (Skin Sensitization) | Assesses possible contact hazards from chemicals, specifically skin sensitization. | Grades Less than 1.0 (<1.0) or no sensitization. Scoring: Less than 1.0 (<1.0), no erythema/oedema. | No evidence of causing skin contact sensitization. |
| ISO 10993-10:2010 (Irritation) | Assesses possible contact hazards from chemicals, specifically skin and mucosal irritation. | Scoring: Less than 1.0 (<1.0), no erythema/oedema. | No erythema/edema; considered non-irritant. |
| ISO 10993-5:2009 (In Vitro Cytotoxicity) | Assesses in vitro cytotoxicity of medical devices. | Number of viable L929 mouse fibroblasts counts in direct method should be more than 70% to pass the test. | Cells beneath test samples did not show signs of cytotoxicity; glove is non-cytotoxic to L-292 cell lines. |
| ISO 10993-10:2010 (Intracutaneous Reactivity) | Evaluated for intracutaneous reactivity potential on single topical application. | Requirement met if difference between test extract mean score and control mean score was 1.0 or less. | No erythema and no edema; considered a non-irritant. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Physical Testing (Freedom of Holes): 500 gloves.
- Sample Size for Residual Powder: Data presented for S, M, L sizes, implying multiple gloves tested per size, but the exact number isn't specified beyond "average powder residue for each size".
- Sample Size for Biocompatibility Tests: Not explicitly stated numerically (e.g., number of animals for skin sensitization/intracutaneous reactivity, number of cell cultures for cytotoxicity), but the results indicate that the studies were performed "Under the conditions of this study," implying established biological testing protocols were followed.
- Data Provenance: The tests are non-clinical (laboratory-based physical and biological assays), not patient data. The document does not specify the country of origin for the testing itself, but the manufacturer is based in Malaysia (AMMEX Malaysia SDN BHD). These are prospective tests performed as part of the submission process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable as the device is a physical examination glove undergoing standardized physical and biocompatibility testing, not an AI/ML-powered diagnostic or interpretive device. The "ground truth" for these tests is established by the test methodology and the measuring equipment/protocols, not by expert human graders or clinicians.
4. Adjudication Method for the Test Set
This is not applicable as the device is a physical examination glove. Standardized laboratory testing methods directly produce results against defined acceptance criteria. There is no human interpretation or adjudication step in the sense of consensus among multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study is not applicable for a physical medical glove. MRMC studies are typically performed for diagnostic imaging devices or AI-assisted interpretation tools to evaluate reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This is not applicable as the device is a physical medical glove, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of these gloves is based on:
- Established ASTM Standards: For physical properties like tensile strength, elongation, freedom of holes, and residual powder.
- Established ISO 10993 Standards for Biological Evaluation: For biocompatibility tests like skin sensitization, irritation, cytotoxicity, and intracutaneous reactivity.
These standards define the acceptable range or qualitative outcome (e.g., non-irritant, non-cytotoxic) that constitutes "meeting the requirement."
8. The Sample Size for the Training Set
Not applicable. This term relates to machine learning models, which are not part of this device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI/ML product, there is no training set or ground truth establishment in this context.
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